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IRB Advisor – May 1, 2021

May 1, 2021

View Archives Issues

  • Pfizer and Moderna Begin COVID-19 Vaccine Trials in Younger Children

    Both Pfizer-BioNTech and Moderna announced in March they had begun clinical trials of their COVID-19 vaccines in children younger than age 12 years. Although public reaction was mixed, researchers and bioethicists now say the timetable for a pediatric vaccine and for the United States to possibly reach herd immunity is early 2022.
  • IRB Staff Training Program Improves Consistency and Work Group Efficiency

    When an IRB office aimed to improve its staff training and work efficiency, the solution was to create a new program, called the IRB Staff Training and Onboarding Program. The process began with the IRB’s internal staff training and member work group and leaders identifying ways to improve training and onboarding of new IRB staff.
  • Reliance Teams Strengthen Relationships with Central IRB

    IRBs and research institutions continue to hammer out processes and best practices related to the revised Common Rule. As one IRB found, this process requires a team effort. When collaborative IRB requests began to increase, the Augusta (GA) University IRB office formed a reliance team. The IRB also designated one team member, a reliance coordinator, to handle issues related to reliance agreements. A recent study revealed the reliance team helps IRB offices with collaboration and reviewing reliance agreements to ensure the research is in accordance with local policies. The team also can help investigators navigate through reliance process.
  • Exploitation Issues Arise in Study of Human Subject Incentive Payments

    As IRBs review participant incentives for studies, they assess whether the incentives are coercive or exploitive. New research provides a snapshot of the diversity of these incentive offerings, revealing monetary payments for biomedical studies tend to be 10 times higher than payments for sociobehavioral studies.
  • Virtual Site Training Expands During the Pandemic

    Virtual training for clinical trial teams may have existed for years, but it has gained significant attention during the COVID-19 pandemic. Experts expect the popularity of this kind of training to increase, even after COVID-19 restrictions are relaxed.